Verona Pharma announced today that it will present extensive data from its Phase 3 ENHANCE clinical program for Ohtuvayre (ensifentrine) at the upcoming American Thoracic Society Conference (ATS) 2025. The company will showcase ten posters, including seven analyses from the ENHANCE studies, two from nonclinical research, and one real-world data analysis.
Ohtuvayre represents a significant advancement in COPD treatment as the first novel inhaled mechanism approved for maintenance therapy in more than two decades. As a selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), the drug uniquely combines bronchodilator and non-steroidal anti-inflammatory effects in a single molecule.
Comprehensive Efficacy Across Diverse COPD Populations
The ENHANCE program analyses demonstrate Ohtuvayre's efficacy across a broad spectrum of COPD patients, including those with comorbidities that often complicate treatment approaches.
Key findings to be presented include data showing that ensifentrine monotherapy significantly improved lung function while reducing exacerbation rates and risk in patients with moderate-to-severe COPD. Dr. Isaac Biney from the University of Tennessee Medical Center will present these results, which support Ohtuvayre as an effective standalone treatment option.
"These analyses provide compelling evidence that Ohtuvayre offers meaningful benefits for COPD patients, including those with complex comorbidities who often face limited treatment options," said a representative from Verona Pharma.
Efficacy in Patients with Comorbidities
Particularly noteworthy are the analyses examining Ohtuvayre's performance in COPD patients with common comorbidities:
Dr. Matthew Moll from Brigham and Women's Hospital will present data showing improved lung function and reduced exacerbation rates in COPD patients with concomitant type 2 diabetes. Similarly, Dr. Nirupama Putcha from Johns Hopkins University will share findings demonstrating comparable benefits in patients with cardiac disorders.
These results are significant as COPD frequently coexists with cardiovascular conditions and metabolic disorders, creating treatment challenges for clinicians who must balance efficacy with safety concerns.
Beyond Lung Function: Quality of Life Improvements
The ENHANCE analyses extend beyond clinical measurements to include patient-reported outcomes. Dr. Michael Bradley Drummond from the University of North Carolina at Chapel Hill will present data showing that ensifentrine monotherapy reduced dyspnea (shortness of breath) and improved quality of life in symptomatic patients with moderate-to-severe COPD.
A separate presentation by Dr. Michael Lester from Vanderbilt University Medical Center will focus specifically on patient-reported outcomes, including dyspnea improvement, in COPD patients with cardiac comorbidities.
Novel Mechanistic Insights
An intriguing post-hoc pooled analysis to be presented by Dr. George Washko from Brigham & Women's Hospital demonstrates that Ohtuvayre reduced exacerbation rates regardless of FEV1 improvement. This suggests the drug's anti-inflammatory properties may provide benefits independent of its bronchodilator effects.
"The finding that Ohtuvayre reduces exacerbations even in patients without significant FEV1 improvement highlights the importance of its dual mechanism of action," noted a respiratory specialist familiar with the data.
Nonclinical Research and Safety Profile
Two nonclinical studies will provide additional insights into Ohtuvayre's properties. A tissue distribution study in rats demonstrated lack of brain exposure following intravenous administration, while a bleomycin model showed antifibrotic effects after inhaled dosing.
These findings contribute to the understanding of Ohtuvayre's safety profile and potential applications beyond COPD maintenance therapy.
Clinical Implications and Future Directions
The comprehensive data to be presented at ATS 2025 reinforces Ohtuvayre's position as an important addition to the COPD treatment armamentarium. The drug's efficacy across diverse patient populations, including those with comorbidities, addresses a significant unmet need in COPD management.
Verona Pharma is also developing a fixed-dose combination of ensifentrine and glycopyrrolate (a long-acting muscarinic antagonist) for COPD maintenance treatment, potentially expanding treatment options for patients requiring multiple mechanisms of action.
Broader Applications Under Investigation
Beyond COPD, Verona Pharma is exploring ensifentrine's potential in other respiratory conditions, including non-cystic fibrosis bronchiectasis, cystic fibrosis, and asthma. The drug's dual bronchodilator and anti-inflammatory properties make it a promising candidate for various respiratory diseases characterized by airway inflammation and bronchoconstriction.
The ATS 2025 conference presentations will provide healthcare professionals with comprehensive data to inform clinical decision-making regarding Ohtuvayre's role in COPD management, particularly for patients with complex presentations and comorbidities.
